Registration Dossier
Registration Dossier
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EC number: 941-570-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin and eye irritation tests with Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid are not available. The similar substance Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid was tested and found to be irritating to both the skin and eyes. Skin irritation studies in rabbits indicate that Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid is irritating to skin. In vitro testing showed that Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid is severly irritant to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation/corrosion:
A skin irritation test with Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid is not available.The similar substance Reaction mass of n-undecanoic-acid and 2-methyl-decanoic-acid and 2-ethyl-nonanoic-acid and 2-propyl-octanoic-acid and 2-butyl-heptanoic-acid was tested according to OECD guideline 404 in compliance with GLP. Under the conditions of the study, the single dermal application of the test item to three rabbits at a dose of 0.5 mL for 4 hours showed slightly irritant effects in all animals directly after patch removal, which were fully reversible within 10 days. Later on desquamation of the skin at the application area were noted. These effects were not fully reversible within 14 days in 2 of 3 animals. No corrosive effects were observed in any animal at any observation time.
In a second supporting study with the analogue 2-butyloctanoic acid (OECD guideline 404, GLP compliant), the single dermal application the test item to three rabbits caused very slight erythema in all animals at the 24 and 48 hour examinations, remaining in 2 animals at the 72 hour examination. Desquamation was noted in all 3 animals after 7 days. Recovery had occurred within 14 days. The results of this study indicate that 2 -butyloctanoic acid has only a slight irritant effect on the skin of the rabbit.
Eye irritation:
An eye irritation test with Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid is not available. An in vitro study was performed to assess serious eye damage of the similar substance Reaction mass of n-undecanoic acid and 2-methyldecanoic acid and 2-ethylnonanoic acid and 2-propyloctanoic acid and 2-butylheptanoic acid by quantitative measurements of changes in opacity and permeability in a bovine cornea following OECD Guideline 437 resp. EU Method B.47 and in accordance with the OECD Principles of Good Laboratory Practice. The test item was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for one hour and whose opacity had been determined. The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured. A mean IVIS of 5.493 was calculated. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS > 3 and ≤ 55 cannot be classified in a UN GHS Category for eye damage with the BCOP test.
The similar substance Reaction mass of n-undecanoic acid and 2-methyldecanoic acid and 2-ethylnonanoic acid and 2-propyloctanoic acid and 2-butylheptanoic acid was further assessed in vitro in the EpiOcularTM Human Cornea Model test. In this study Reaction mass of n-undecanoic acid and 2-methyldecanoic acid and 2-ethylnonanoic acid and 2-propyloctanoic acid and 2-butylheptanoic acid was applied to a three-dimensional human cornea model tissue for three different exposure times in duplicate (3 min., 30 min. and 60 min.). 100 μL of the liquid test item were applied to each tissue. After treatment, the substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT which can be reduced to a blue formazan. Formazan production was measured by measuring the optical density (OD) of the resulting solution. After 3 minutes treatment with the test item, the relative absorbance values increased to 106.4 %. After 30 minutes treatment, relative absorbance values were reduced to 35.3 %. And after 60 minutes treatment the relative absorbance values were reduced to 34.5 %. From these values the ET50 was calculated mathematically. The calculated ET50 of the test item was 24.43 min. Therefore, the test item Reaction mass of n-undecanoic acid and 2-methyldecanoic acid and 2-ethylnonanoic acid and 2-propyloctanoic acid and 2-butylheptanoic acid is considered as moderate eye irritant in the EpiOcularTM Human Cornea Model test.
In a supporting study with the analogue 2-butyloctanoic acid was tested in an OECD guideline 405 study in compliance with GLP. The test item was instilled undiluted in an amount of 0.1 ml to the eyes of 3 rabbits. Well defined conjunctival redness, chemosis and ocular discharge in all three animals one hour after application which remained in one animal at the 24 hours examination were observed. In the remaining two animals slight redness, chemosis and discharge were noted at the 24 hour reading. At the 48 hour examination only slight conjunctival redness was observed in two animals. All effects were fully reversible within 72 hours. The results of this study indicate that 2-butyloctanoic acid has only a slight irritant effect in the eye which would not lead to classification.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
According to the classification criteria of regulation (EC) 1272/2008 Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid has to be classified with Skin Irrit. 2, H315 and Serious Eye Irrit. 2, H319.
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